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Immunogenicity

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Why

The clinical implications of drug immunogenicity vary widely from no effect (i.e. rh-GH), to life threatening situations

  • 1. Changes in pharmacokinetics (i.e. rh-Insulin, therapeutic antibodies)
  • 2. Reduction in efficacy (i.e. GM-CSF, IFNalpha, IFNbeta, therapeutic antibodies)
  • 3. Cross reaction with endogenous protein (i.e. FVIII, FIX, rh-MDGF, rh-EPO)

There are product related factors to consider (formulation and impurities) as well as patient and disease related factors (genetics, duration, route of administration).

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